SCARFix™ Locking Plate FH04042

GUDID 04048266140821

TiAl6V4 ELI non-sterile

Merete GmbH

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 04048266140821
• NIH Device Record Key: 33892d2b-69b0-4502-baa7-bc8a831debf4
• Commercial Distribution Discontinuation: 2019-04-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SCARFix™ Locking Plate
• Version Model Number: left 42
• Catalog Number: FH04042
• Company DUNS: 313267265
• Company Name: Merete GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 630-613-7182
• Email: service@merete.medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com
• Phone: +1(630)869-1092
• Email: service@merete-medical.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04048266140821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140069

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

[04048266140821]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-05
• Device Publish Date: 2015-10-15

On-Brand Devices [SCARFix™ Locking Plate]

• 04048266140883: TiAl6V4 ELI non-sterile
• 04048266140869: TiAl6V4 ELI non-sterile
• 04048266140852: TiAl6V4 ELI non-sterile
• 04048266140838: TiAl6V4 ELI non-sterile
• 04048266140821: TiAl6V4 ELI non-sterile
• 04048266140807: TiAl6V4 ELI non-sterile
• 04048266140791: TiAl6V4 ELI non-sterile
• 04048266140777: TiAl6V4 ELI non-sterile
• 04048266140876: TiAl6V4 ELI non-sterile
• 04048266140845: TiAl6V4 ELI non-sterile
• 04048266140814: TiAl6V4 ELI non-sterile
• 04048266140784: TiAl6V4 ELI non-sterile